IRB #

IRB00001012

Title

A Phase II Study of Patients with Newly Diagnosed Primary Central Nervous System Lymphoma Treated with Methotrexate/BBBD, and Adding Rituximab (an anti CD-20 Antibody) and Carboplatin, to the Treatment Regimen

Principal Investigator

Edward Neuwelt

Study Purpose

The purpose of this study is to evaluate the safety and tolerability of chemotherapy delivered in conjunction with a special technique called blood-brain barrier disruption (BBBD) in patients with primary central nervous system lymphoma (PCNSL) who have not undergone prior cranial or spinal radiotherapy. Participants of this study will be hospitalized for approximately three days every four weeks, to receive chemotherapy. The drug rituximab will be administered intra-venously, the evening prior to carboplatin (intra-arterial) and methotrexate (intra-arterial) chemotherapy. The two chemotherapy drugs will be administered in conjunction with BBBD. If the patient has lymphoma in the eye, chemotherapy will be given into the eye(s) as well. Participants will receive the drug sodium thiosulfate (intra-venous) four and eight hours after carboplatin, in an effort to reduce side effects associated with this chemotherapy regimen. The treatment may continue for up to 12 months in the absence of disease progression or unacceptable side effects.

Medical Condition(s)

Brain & Nervous System

Eligibility Criteria

Primary central nervous system lymphoma (PCNSL)
No prior cranial or spinal radiotherapy
No systemic lymphoma
No more than 90 days since diagnosis of PCNSL
Must be HIV negative
Must be Hepatitis B and Hepatitis C negative
Age 18 to 75 years

Age Range

18 - 75

Healthy Volunteers Needed

No

Duration of Participation

The treatment may continue for up to 12 months in the absence of disease progression or unacceptable side effects.

Minors Included

No

Contact

Edward A Neuwelt, MD 503-494-5626 neuwelte@ohsu.edu

Sponsor

National Cancer Institute

Recruitment End

Compensation Provided

No